APO-LANSOPRAZOLE ODT

What it is

APO-LANSOPRAZOLE ODT is a lansoprazole 15 mg or 30 mg orally disintegrating tablet. Each tablet contains lansoprazole active ingredient and excipients including aspartame, phenylalanine and sulfites. The tablets are strawberry flavoured and should be placed on the tongue and gently sucked, where they rapidly disperse in the mouth, releasing enteric-coated microgranules, which are swallowed with the patient's saliva.

Approved indications

**Adults:** — Healing and long-term management of reflux oesophagitis. — Healing and long-term management for patients with duodenal ulcer. — Healing of benign gastric ulcer. — Treatment in patients with benign peptic lesions that do not respond to H2-receptor antagonists. — Eradication of H. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics. — Relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia. **Paediatric patients 6 to 17 years of age:** — Treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. — Healing of erosive oesophagitis.

Dosing overview

Lansoprazole once daily should be administered in the morning before food to achieve the optimal acid inhibitory effect and hence most rapid healing and symptom relief. The tablet can be swallowed whole with a drink of water. For children 6 to 11 years with reflux oesophagitis, the recommended dose is 15 mg once daily for up to 12 weeks for those weighing ≤30 kg or 30 mg once daily for up to 12 weeks for those weighing >30 kg. For children 12 to 17 years with erosive oesophagitis, the recommended dose is 30 mg once daily for up to 8 weeks. For non-erosive GERD in this age group, the recommended dose is 15 mg once daily for up to 8 weeks.

Key safety warnings

When a gastric ulcer is suspected, the possibilities of malignancy should be excluded since treatment may alleviate symptoms and possibly delay diagnosis. Similarly, serious underlying disease such as malignancy should be excluded before treatment for dyspepsia commences, particularly in patients of middle age or older with new or recently changed dyspeptic symptoms. Agents that elevate gastric pH may increase the risk of nosocomial pneumonia in intubated ICU patients receiving mechanical ventilation. Acid-reducing drugs may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter. Proton pump inhibitor therapy may be associated with an increased risk of Clostridium difficile infection. Daily treatment with acid-suppressing medications over a long period of time (longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. PPIs, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Acute tubulointerstitial nephritis has been observed in patients taking PPIs including lansoprazole and may occur at any point during PPI therapy. Severe hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, with serious adverse events including fatigue, tetany, seizures, dizziness and ventricular arrhythmias. Severe cutaneous adverse reactions, including Stevens–Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalised exanthematous pustulosis and erythema multiforme have been reported in association with PPIs. Discontinue lansoprazole at the first signs or symptoms of severe cutaneous adverse reactions.

Contraindications

Hypersensitivity to lansoprazole, other proton pump inhibitors or any of the excipients. Severe hepatic impairment. APO-LANSOPRAZOLE ODT should not be co-administered with atazanavir due to a significant reduction in atazanavir exposure.

Regulatory history

APO-LANSOPRAZOLE ODT lansoprazole 15 mg and 30 mg orally disintegrating tablet blister packs were first listed on the ARTG on 19 November 2014.